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New treatment option for Glaucoma,Open-Angle
Official title Transscleral Selective Laser Trabeculoplasty Project
ClinicalTrials.gov ID: NCT06833060
What this study is testing
- What it's testing
- The purpose of this clinical trial is to determine how safe and effective (how well it works) the ELLEX TSLT device is for the treatment of Glaucoma and Ocular Hypertension using Transscleral Selective Laser Trabeculoplasty. Selective Laser Trabeculoplasty (SLT) is a type of laser therapy that uses short pulses of low-energy light to lower eye pressure.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older with OAG or OHT who are clinical candidates for routine SLT.
- Mild to moderate OAG (defined as a mean deviation on the Humhprey Field Analyzer [HFA] \> -12.0 dB), resulting from primary open-angle glaucoma...
- OHT with open angles warranting IOP-lowering treatment
- IOP ≥ 22mmHg or ≤ 35mmHg (after washout of any IOP-lowering medications)
- Gonioscopically visible scleral spur for 360 degrees without indentation
You likely can't join if
- Contraindications to conventional SLT (e.g. corneal abnormalities etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma included pigmentary glaucoma
- Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
- Presence of any peripheral anterior synechiae (PAS) in the study eye
See the full eligibility criteria
- Age 18 years or older with OAG or OHT who are clinical candidates for routine SLT.
- Mild to moderate OAG (defined as a mean deviation on the Humhprey Field Analyzer [HFA] \> -12.0 dB), resulting from primary open-angle glaucoma (POAG), or pseudoexfoliative glaucoma
- OHT with open angles warranting IOP-lowering treatment
- IOP ≥ 22mmHg or ≤ 35mmHg (after washout of any IOP-lowering medications)
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a manual elevation of the lid)
- Willing and able to participate in the 60 days +/-5 days study, to comply with the study procedures and to adhere to the follow-up schedule.
- Participant capable of giving informed consent
- Contraindications to conventional SLT (e.g. corneal abnormalities etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma included pigmentary glaucoma
- Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
- Presence of any peripheral anterior synechiae (PAS) in the study eye
- Any of the following visual field findings using the Humphrey visual field analyzer:
- A HFA MD of worse than -12dB
- Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
- At least 50% of points (i.e., 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
- Points within the central 5 degrees of fixation with a sensitivity \<15 dB in both hemifields on the decibel plot
- A visual field MD of worse than -12dB in the fellow eye
- Cup: Disc Ratio more than 0.8
- More than two hypotensive medications required (combination drops are considered 2 medications)
- Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye
- Prior corneal refractive surgery
- Complicated cataract surgery ≤ 6 months prior to enrollment
- Presence of visually significant cataract in the opinion of the investigator
- Clinically significant disease in either eye as determined by the Investigator
- Clinically significant amblyopia in either eye
- Dense pigmentation or hemorrhage in the peri-limbal conjunctiva or anterior sclera, Pigmented Pinguecula and Pterigium
- Women who are pregnant or may become pregnant during the course of the study
- In the opinion of the investigator the participant might require other ocular surgery within the 12-months, unless for further reduction of their IOP.
- Concurrent treatment with topical, nasal, inhaled or systemic steroids.
- Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
- Participation in another clinical study
- Protected or vulnerable people (including but not limited to people with impaired intellectual functioning or mental illness, prisoners, terminally ill people, immunocompromised…)
- People not able to read and understand the informed consent
- People not able to read and understand English language
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.